Cleared Traditional

K212522 - Lilliput APD System

K212522 is an FDA 510(k) clearance for Lilliput APD System, manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K212522 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2022
Decision
247d
Days
Class 2
Risk

K212522 is an FDA 510(k) clearance for the Lilliput APD System. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on April 15, 2022 after a review of 247 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius Medical Care Renal Therapies Group, LLC devices

FDA 510(k) Submission Details - K212522

510(k) Number K212522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2021
Decision Date April 15, 2022
Days to Decision 247 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 131d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKX Device Classification - Class 2, Special Controls

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FKX System, Peritoneal, Automatic Delivery

All 64
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K212522.
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K181108 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018